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Critical drug shortage: 500,000 cancer patients may lose access to lifesaving treatments

Kristen Landau feared the 'what ifs' when she was told her chemotherapy drug was unavailable (Photo: Kristen Landau){p}{/p}
Kristen Landau feared the 'what ifs' when she was told her chemotherapy drug was unavailable (Photo: Kristen Landau)

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Cancer patients across the country are facing a gut-wrenching reality: The critical drugs that could save their lives aren't available.

More than a dozen drugs used to treat common cancers are in short supply, forcing doctors to make devastating choices about how to distribute what little amount they have.

This isn’t the first time the shortages have happened, and experts say we’ve failed to find long-term solutions to ensure it doesn’t happen again.

Kristen Landau is an energetic mom of two who owns her own yoga studio in Iowa. She spends her days practicing yoga and chasing her young boys, ages 2 and 3, around a busy home.

Last year, she was diagnosed with cancer at just 39 years old.

She was blindsided by the news. Landau says she has no family history of cancer and was in the best shape of her life when the diagnosis came.

Heartbreaking questions came rushing to her mind.

"It was very scary. My boys are so little, they need a mom," she said. "I told (my doctor), 'Do everything that you have to do without killing me so we can get rid of this and so I can be a mom to my kids.'"

Landau said she wasn't sure if she would make it to her 40th birthday, but she did, thanks to aggressive treatment and a chemotherapy drug called carboplatin.

By last fall, the spots on her liver had disappeared, and the tumor in her breast had shrunk. Since November, she had no evidence of disease in her scans.

Landau told Spotlight on America her course of treatment was going great "until the chemo shortage happened."

This spring, the drug that shrunk her tumor and was halting the spread of her disease was no longer available.

"Any time you change things up, it's terrifying," Landau told us. "You just want to stick with what works."

But she had no choice, and she was not alone. As many as 500,000 Americans have been dealt the devastating double blow of a cancer diagnosis and unavailable life-saving drugs.

According to the FDA's website, 15 drugs for cancer treatment are in short supply right now.

Among them are drugs known as cisplatin and carboplatin, sterile injectables that are some of the most commonly used and relied upon chemotherapy drugs, ones that Dr. Kristen Rice calls crucial.

According to the National Cancer Institute, cisplatin and other similar drugs are prescribed for an estimated 10% to 20% of all cancer patients.

"Those drugs are the backbone of therapy for lung cancer, ovarian cancer, bladder cancer, testes cancer, a host of other common and potentially curable cancers," Rice said. "The next best treatment is not as good."'

Rice has been treating patients in San Diego for 12 years. She showed Spotlight on America an email from the supplier that provides drugs for her patients. Next to the drugs, chilling words: "low supply," "strictly allocated," "back ordered," and "production problems."

When she saw that email, she described her reaction in one word: terror.

"It's incredibly stressful for us and our patients to deal with these shortages," she told us, adding that she has had to alter patients' treatment plans because drugs were unavailable.

Rice put her frustration into writing, publishing an article in STAT titled "Cancer drug shortages should have patients rioting in the streets."

"People just don't know, they don't know how this works, they don't know that there are no fail-safes in place to keep us from running out of critical medications. I didn't know that either," said Rice. "It's so messy, and it's so complicated, and I don't know how it got this way, but we have to fix it."

Right now, there's no long-term fix in sight, and experts say the shortage is more widespread than ever.

According to the National Comprehensive Cancer Network, this spring, 93% of cancer centers surveyed reported a shortage of carboplatin. And 70% were short on cisplatin.

This shortage is widely considered the worst in decades, but the problem isn't new. In 2019, the FDA released a study of the dangers and root causes of drug shortages. But four years later, it's clear there's been no substantive change to prevent shortages from continuing.

Understanding how we got here requires a look at medical economics.

The cancer drugs now in short supply are older, generic medications. They're cheap to buy, as low as a few dollars a dose.

Because they have a low profit margin, companies aren't incentivized to make them.

The manufacturers that do make the drugs are not in the U.S. They are largely located overseas, in China and India, in factories that receive little or no oversight.

Rice told Spotlight on America that makes it harder for the FDA to oversee the quality of the products, or understand how much of a drug is being made.

"We've really lost all control of the process," said Rice. "The FDA doesn't really have a way to monitor the supply, and they certainly don't have the ability to foresee changes that may drive up demand for a drug or that may harm the supply of a drug in the near future, which makes it really hard to respond to shortages."

This spring, a Senate report found the FDA, charged with protecting public health "still lacks critical information that could help mitigate shortages."

Right now, manufacturers don't have to report increased demand or export restrictions to the agency. The FDA told lawmakers it has some information about the sources of raw materials for drug products but admitted it can't use the data to predict shortages because the information is "unstructured" and "buried in PDFs."

Late last year, a factory in India run by Intas Pharmaceuticals that makes an estimated half of our carboplatin and cisplatin supply shut down production after a 36-page report from the FDA found several violations, including a worker pouring acid in a bin of documents to destroy evidence of problematic results.

Fast forward nine months, the FDA followed up with a warning letter in late July, nothing the problems had continued.

Failures thousands of miles away continue to leave providers such as Rice not only scrambling to create a plan for their patients but trying to figure out solutions.

"I did not get trained to manage drug supply chains and figure out the complicated economics of drug developments in the United States," she said. "But here I am."

To ease the crisis in the short term, the FDA is allowing the import of cisplatin from a factory in China.

FDA Commissioner Robert Califf said of the new imports, "We very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients."

But the Band-Aid imports won't fix a long-standing problem.

For now, Landau, the Iowa mom, has switched to a different drug, one that makes her sicker but seems to be working.

Even if carboplatin returns, the once plentiful drug will be rationed, and Landau told us she won't be eligible for it because her cancer is considered Stage 4 because it had spread.

Landau is keeping a positive attitude as she continues her battle with the disease.

"I have cancer either way, if I'm miserable, I'm crabby about it all the time, or if I'm a positive person," she said. "So, I'd rather be the happy, positive person."

Still, she told us she's frustrated and confused about the roots of the shortage that upended her treatment. Spotlight on America discovered there are multiple factors involved, and several entities that share responsibility.

The FDA admits it has blind spots when it comes to supply and demand of crucial drugs. The White House has convened a task force on the issue, but no recommendations or findings have been issued. And Congress has floated legislation and held hearings but has taken no concrete action.

Landau's message to anyone with the power to take action is simple.

"Figure it out," she said.

Spotlight on America is working on a follow-up report to investigate when concrete action may happen. We sat down with Congressman Brian Fitzpatrick, R-Pa., a co-chair of the Congressional Cancer Caucus for an exclusive interview about what's being done to solve this problem. Our next report will be published later this week.

Spotlight on America reached out to Intas Pharmaceuticals to ask about the violations at their plant in India. They did not return our request for comment.

In response to our inquiry about drug shortages, the FDA sent us this statement:

"The FDA recognizes that a robust, resilient and safe drug supply chain is essential for public health and national security. The agency is fully engaged in cross-government discussions to identify potential policies and provide input on proposals informed by our current authorities, resources and industry knowledge to ensure meaningful solutions.

We remain committed to partnering across government, academia, and industry to strengthen and diversify the supply chain, further address drug shortages and ensure Americans continue to have access to drugs that are of high quality, safe and effective.

While the FDA cannot directly affect many of the business decisions related to the drug supply chain, the agency has, among other things, encouraged the adoption of advanced manufacturing technologies and mature quality management practices to further these important efforts."

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